E-drug: Quality control of essential drugs (cont)
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In the 80s Laos had experienced a similar situation where drug regulatory
authority (the MOH Department of Pharmacy) had no drug quality control
facility/laboratory to perform quality testing for both locally produced and
imported pharmaceuticals. What we did was to utilise the quality testing
facilities, including equipment and reagents, of the domestic drug
manufacturers and the university's laboratory. From our experience
there are a few very important points need to be considered from a
technical,
professional and regulatory point of view:
1. Testing equipment/instrument's calibration: it is important to make sure
that all instruments used are well-calibrated based on instructions of
manufacturers and the set requirements/standards. This is to be done
before the tests/essays begin. [note: often times it is good to
compare the new calibration results/data to that of the drug
manufacturers' to see whether there is any difference/inconsistency].
2. References for testing/analysing methods and techniques. If the drug
industry do not provide or specify the references for the
methods/techniques of testing, the officially accepted
pharmacopoeia(s) or the officially approved methods/techniques
developed by the drug regulatory authority should be applied.
3. The reagents (including testing chemicals, solvents, indicators) have to
be checked for their quality standards (they need to be conformed with
testing/analysing quality grade).
4. Analysts should be the qualified drug testing personnel of MOH (if
available) or independent testing people that could be hired from other
countries. Avoiding to employ or designate personnel from the industry (as
much as possible) to carry out quality control testing to certify and/or
evaluate for registration/licensing/marketing purposes. We all know that
drug quality control regulatory authority is the agency that the public
could rely upon for the safety, efficacy, and quality of the pharmaceuticals
they consume.
For registration/licensing/marketing of a drug: in some cases where
there is a (significant) difference of results from a test/analysis
carried out by
the drug industry compared to the results obtained by the regulatory
personnel, the quality testing/analysis need to be redone by the industry.
If there is still non-conformation, both the drug regulatory authority and
the industry need to appoint their testing person to carry the testing in
the same environment (testing methods/techniques) using the same
reagents and instruments.
5. In some difficult cases the drug regulatory authority should seek help
from neighbouring (or a country which has the capacity) countries to
perform the testing/analyses.
6. Sampling: taking samples for testing forms a very crucial part of a drug
quality testing process. Sampling has to be done according to its rules (in
some instances you may need more samples than it is required eg. from a
suspected batch of products) and has to be taken by experienced drug
regulatory personnel.
With best wishes,
Souly Phanouvong, B.Pharm, D.Pharm, PhD
Former Drug Inspector and Drug Quality Analyst
Ministry of Public Health of Laos
Currently:
Therapeutic Guidelines
Level 2, 55 Flemington Road
North Melbourne, Vic 3051 Australia
Phone: (61 3) 9326 9959
Fax: (61 3) 9326 5632
Therapeutic Guidelines website: http://www.tg.com.au
"Souly Phanouvong" <sphanouvong@tg.com.au>
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